Comparing two methods for treating wide-neck abdominal aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The HERCULES trial is a randomized controlled clinical trial that aims to compare the clinical outcomes of endosuture aneurysm repair (ESAR) using the Heli-FX EndoAnchor system against standard endovascular aneurysm repair (EVAR) with the Endurant II/IIs stent graft system. This multicenter trial will recruit up to 300 subjects across 40 sites in Europe and the US, focusing on patients with infrarenal abdominal aortic aneurysms that have wide proximal neck diameters. Participants will be followed for up to five years to assess the effectiveness and safety of both treatment methods. The study is designed to fill the gap in clinical evidence regarding these two approaches in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Provided written informed consent
* Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
* Elective repair
* Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
* Infrarenal neck diameter ≥ 28 mm and ≤32 mm
* Proximal neck length ≥10mm

Exclusion Criteria:

* Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
* Planned use of AUI main body device
* Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study.
* Patient with eGFR \< 30 ml/min/1.73m2 before the intervention
* Patient's life expectancy \<2 years as judged by the investigator
* Patient has a psychiatric or other condition that may interfere with the study
* Patient has a known allergy to any device component
* Patients with a systemic infection who may be at increased risk of endovascular graft infection.
* Patient has a coagulopathy or uncontrolled bleeding disorder
* Patient has a ruptured, leaking, or mycotic aneurysm
* Patient is not eligible for standard EVAR
* Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
* Patient is pregnant (Female patients of childbearing potential only)
* Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure.
* Patient has previously been treated with stent grafts in the aorto-iliac arteries

Where it's running

• Washington Regional Medical Center
  Washington, Arkansas, United States Recruiting
• Mt Sinai Med Ctr
  Miami Beach, Florida, United States Recruiting
• Loyola
  Maywood, Illinois, United States Recruiting
• Beaumont University Hospital
  Royal Oak, Michigan, United States Recruiting
• Alina Health
  Minneapolis, Minnesota, United States Recruiting
• University of Missouri
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: MMPJ Reijnen, Prof. Dr. — Rijnstate, Arnhem, the Netherlands
• Study coordinator: Suzanne Holewijn, PhD
• Email: herculestrial@rijnstate.nl
• Phone: 0031880057282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.